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Lost needle tip during hysterectomy
CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.
The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.
The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.
Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.
Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.
Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”
Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.
The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.
What’s the verdict?
A defense verdict was awarded.
Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:
- stress incontinence (associated with loss of urine with sneezing, coughing, and exercise)
- urge incontinence (inability to reach the bathroom in time)
- frequency of urination, especially while sleeping
- overflow incontinence
- overall loss of bladder control.
Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?
The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.
From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.1 The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.2 Once a device comes upon the radar screen of the US Food and Drug Administration for significant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.
Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.
Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.
Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.
Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.
Some additional areas of potential claims for liability in this case include:
- The explanation for the needle breaking during surgery is unclear from the brief statement of case facts. There might be malpractice liability if the surgeon was unreasonable in how the needle was used, used the wrong needle, or ignored defects in the needle.
- The surgeon tried unsuccessfully to retrieve the needle during the original surgery. If the surgeon’s failure to retrieve the needle was because of inadequate training, lack of care or the like, it might be seen as the “cause” of the patient’s injuries.
- The fact that a second surgeon was able to remove the needle tip, which resolved the patient’s pain, may raise the question of whether the first surgeon’s decision not to seek to remove it in response to the continuing pain was reasonable. If the first surgeon did not want to remove the needle tip, a question might be raised about whether that surgeon should have referred the patient to another surgeon. (The patient ultimately found another surgeon on her own.)
- Regarding use of TOT: A 21.5% complication rate ordinarily would be a significant factor to consider in a decision to use the tape. Physicians are responsible for keeping up with current developments in the devices and pharmaceuticals they use. Therefore, if information on the complication rate was available, the surgeon’s documentation should reflect the basis for choosing to use the tape. More important, the surgeon should document a conversation with the patient about the risks and benefits of using the TOT and the discussion of alternatives to its use.
What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.
A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.
No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. Bladder sling risks, complications and side effects. DrugWatch Web site. http://www.drugwatch.com/trans vaginal-mesh/bladder-sling/. Updated January 2, 2015. Accessed February 13, 2015.
2. Boyles SH, Edwards R, Gregory W, Clark A. Complications associated with transobturator sling procedures. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(1):19–22.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
The authors report no financial relationships relevant to this article.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
The authors report no financial relationships relevant to this article.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
The authors report no financial relationships relevant to this article.
CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.
The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.
The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.
Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.
Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.
Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”
Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.
The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.
What’s the verdict?
A defense verdict was awarded.
Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:
- stress incontinence (associated with loss of urine with sneezing, coughing, and exercise)
- urge incontinence (inability to reach the bathroom in time)
- frequency of urination, especially while sleeping
- overflow incontinence
- overall loss of bladder control.
Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?
The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.
From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.1 The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.2 Once a device comes upon the radar screen of the US Food and Drug Administration for significant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.
Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.
Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.
Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.
Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.
Some additional areas of potential claims for liability in this case include:
- The explanation for the needle breaking during surgery is unclear from the brief statement of case facts. There might be malpractice liability if the surgeon was unreasonable in how the needle was used, used the wrong needle, or ignored defects in the needle.
- The surgeon tried unsuccessfully to retrieve the needle during the original surgery. If the surgeon’s failure to retrieve the needle was because of inadequate training, lack of care or the like, it might be seen as the “cause” of the patient’s injuries.
- The fact that a second surgeon was able to remove the needle tip, which resolved the patient’s pain, may raise the question of whether the first surgeon’s decision not to seek to remove it in response to the continuing pain was reasonable. If the first surgeon did not want to remove the needle tip, a question might be raised about whether that surgeon should have referred the patient to another surgeon. (The patient ultimately found another surgeon on her own.)
- Regarding use of TOT: A 21.5% complication rate ordinarily would be a significant factor to consider in a decision to use the tape. Physicians are responsible for keeping up with current developments in the devices and pharmaceuticals they use. Therefore, if information on the complication rate was available, the surgeon’s documentation should reflect the basis for choosing to use the tape. More important, the surgeon should document a conversation with the patient about the risks and benefits of using the TOT and the discussion of alternatives to its use.
What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.
A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.
No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.
The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.
The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.
Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.
Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.
Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”
Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.
The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.
What’s the verdict?
A defense verdict was awarded.
Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:
- stress incontinence (associated with loss of urine with sneezing, coughing, and exercise)
- urge incontinence (inability to reach the bathroom in time)
- frequency of urination, especially while sleeping
- overflow incontinence
- overall loss of bladder control.
Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?
The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.
From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.1 The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.2 Once a device comes upon the radar screen of the US Food and Drug Administration for significant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.
Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.
Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.
Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.
Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.
Some additional areas of potential claims for liability in this case include:
- The explanation for the needle breaking during surgery is unclear from the brief statement of case facts. There might be malpractice liability if the surgeon was unreasonable in how the needle was used, used the wrong needle, or ignored defects in the needle.
- The surgeon tried unsuccessfully to retrieve the needle during the original surgery. If the surgeon’s failure to retrieve the needle was because of inadequate training, lack of care or the like, it might be seen as the “cause” of the patient’s injuries.
- The fact that a second surgeon was able to remove the needle tip, which resolved the patient’s pain, may raise the question of whether the first surgeon’s decision not to seek to remove it in response to the continuing pain was reasonable. If the first surgeon did not want to remove the needle tip, a question might be raised about whether that surgeon should have referred the patient to another surgeon. (The patient ultimately found another surgeon on her own.)
- Regarding use of TOT: A 21.5% complication rate ordinarily would be a significant factor to consider in a decision to use the tape. Physicians are responsible for keeping up with current developments in the devices and pharmaceuticals they use. Therefore, if information on the complication rate was available, the surgeon’s documentation should reflect the basis for choosing to use the tape. More important, the surgeon should document a conversation with the patient about the risks and benefits of using the TOT and the discussion of alternatives to its use.
What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.
A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.
No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.
Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.
1. Bladder sling risks, complications and side effects. DrugWatch Web site. http://www.drugwatch.com/trans vaginal-mesh/bladder-sling/. Updated January 2, 2015. Accessed February 13, 2015.
2. Boyles SH, Edwards R, Gregory W, Clark A. Complications associated with transobturator sling procedures. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(1):19–22.
1. Bladder sling risks, complications and side effects. DrugWatch Web site. http://www.drugwatch.com/trans vaginal-mesh/bladder-sling/. Updated January 2, 2015. Accessed February 13, 2015.
2. Boyles SH, Edwards R, Gregory W, Clark A. Complications associated with transobturator sling procedures. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(1):19–22.
Could thorough documentation have changed the outcome of this trial?
Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.
Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.
The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.
Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.
The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.
Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.
The case went to trial.
What’s the verdict?
CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.
Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.
A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the circumstances during which the patient’s consent was obtained.
State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:
- the nature of the procedure proposed
- the risks and benefits of the procedure
- the alternative forms of treatment
- the consequences of not undertaking the proposed procedure or an alternative.
In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.
Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:
- the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
- the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.
The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.
We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!
A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.
Litigation prevention rule #1: Thorough documentationVital elements to document | |
| Preoperative office-visit records
Written consent form
| Operative report
Postoperative office-visit records
|
*In the event of an adverse outcome, your actions will be judged on whether you were acting reasonably and using your best judgment. Your documentation needs to explain in detail what you did and why you did it that way. If what you did was a “variance,” explain why. | |
Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.
The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.
Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind.
WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com
Please include the city and state in which you practice.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
Dr. Sanfilippo reports being on the advisory board for Bayer Healthcare Pharmaceuticals and Smith and Nephew. Mr. Smith and Ms. Pruitt report no financial relationships relevant to this article.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
Dr. Sanfilippo reports being on the advisory board for Bayer Healthcare Pharmaceuticals and Smith and Nephew. Mr. Smith and Ms. Pruitt report no financial relationships relevant to this article.
| Joseph S. Sanfilippo, MD, MBA Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology & Infertility at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors. |
| Steven R. Smith, JD |
| Shirley M. Pruitt, BSN, JD |
Disclosures
Dr. Sanfilippo reports being on the advisory board for Bayer Healthcare Pharmaceuticals and Smith and Nephew. Mr. Smith and Ms. Pruitt report no financial relationships relevant to this article.
Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.
Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.
The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.
Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.
The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.
Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.
The case went to trial.
What’s the verdict?
CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.
Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.
A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the circumstances during which the patient’s consent was obtained.
State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:
- the nature of the procedure proposed
- the risks and benefits of the procedure
- the alternative forms of treatment
- the consequences of not undertaking the proposed procedure or an alternative.
In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.
Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:
- the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
- the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.
The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.
We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!
A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.
Litigation prevention rule #1: Thorough documentationVital elements to document | |
| Preoperative office-visit records
Written consent form
| Operative report
Postoperative office-visit records
|
*In the event of an adverse outcome, your actions will be judged on whether you were acting reasonably and using your best judgment. Your documentation needs to explain in detail what you did and why you did it that way. If what you did was a “variance,” explain why. | |
Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.
The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.
Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind.
WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com
Please include the city and state in which you practice.
Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.
Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.
The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.
Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.
The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.
Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.
The case went to trial.
What’s the verdict?
CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.
Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.
A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the circumstances during which the patient’s consent was obtained.
State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:
- the nature of the procedure proposed
- the risks and benefits of the procedure
- the alternative forms of treatment
- the consequences of not undertaking the proposed procedure or an alternative.
In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.
Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:
- the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
- the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.
The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.
We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!
A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.
Litigation prevention rule #1: Thorough documentationVital elements to document | |
| Preoperative office-visit records
Written consent form
| Operative report
Postoperative office-visit records
|
*In the event of an adverse outcome, your actions will be judged on whether you were acting reasonably and using your best judgment. Your documentation needs to explain in detail what you did and why you did it that way. If what you did was a “variance,” explain why. | |
Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.
The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.
Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)
Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind.
WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com
Please include the city and state in which you practice.
